You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Instructor:
Henry Urbach
Product ID: 702964
- Duration: 60 Min
Why Should You Attend:
Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk.
GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
Areas Covered in the Webinar:
- What is an objectionable microbe?
- Pathogens vs. objectionables
- Just how objectionable is it?
- Consider the risk
- Performing a risk assessment
- Examples
Who Will Benefit:
All FDA regulated companies will benefit from this webinar - pharmaceutical, biotech, medical device companies and laboratories.
- Quality system auditors
- QA directors and managers
- Information technology managers and personnel
- Microbiology analysts and technicians
- Consultants
- Regulatory and Compliance Management
- Microbiologists
Henry Urbach
Principal, GMP TDC LLC
Henry Urbach is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving life sciences industries. He has over 20 years of life sciences experience having held positions of increased responsibility in training, QA, and QC microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.
More Training By Experts
- Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
- Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
- Creating Effective SOPs for Regulatory Compliance
- Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
- Creating FDA-compliant cGMP Training Program
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
